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FI3844189T3 - Dosing strategy to mitigate cytokine release syndrome of bispecific CD3/CD20 antibodies - Google Patents

Dosing strategy to mitigate cytokine release syndrome of bispecific CD3/CD20 antibodies Download PDF

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Publication number
FI3844189T3
FI3844189T3 FIEP19782800.7T FI19782800T FI3844189T3 FI 3844189 T3 FI3844189 T3 FI 3844189T3 FI 19782800 T FI19782800 T FI 19782800T FI 3844189 T3 FI3844189 T3 FI 3844189T3
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FI
Finland
Prior art keywords
dose
therapeutic protein
subject
use according
lymphoma
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FIEP19782800.7T
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Finnish (fi)
Inventor
Carrie Brownstein
Israel Lowy
Lieve Lucille Adriaens
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Regeneron Pharma
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Publication of FI3844189T3 publication Critical patent/FI3844189T3/en

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Claims (14)

PATENTTIVAATIMUKSETPATENT CLAIMS 1. Terapeuttinen proteiini käytettäväksi CD20+ B-solulymfooman hoitomenetelmässä, jolloin menetelmä käsittää sen, että kohteelle annetaan terapeuttinen proteiini annostusohjelmassa sytokiinien vapautumisoireyhtymän tai — infuusioon liittyvän reaktion esiintyvyyden tai vakavuuden vähentämiseksi, joka menetelmä käsittää: annetaan terapeuttisen proteiinin ensisijaisen annoksen (D1) fraktioita annostusohjelman viikolla 1, jolloin ensisijainen annos käsittää 1 mg terapeuttista proteiinia, ensimmäinen annosfraktio (F1D1) käsittää 50 % ensisijaisen annoksen — kokonaismäärästä ja se annetaan kohteelle viikon 1 päivänä 1, ja toinen annosfraktio (F2D1) käsittää loput 50 % ensimmäisen annoksen kokonaismäärästä ja se annetaan kohteelle 12—96 tunnin kuluttua F1D1:stä; annetaan terapeuttisen = proteiinin — toissijaisen annoksen (D2) €fraktioita annostusohjelman viikolla 2, jolloin toissijainen annos käsittää 20 mg terapeuttista — proteiinia, ensimmäinen annosfraktio (F1D2) käsittää 50 % toissijaisen annoksen kokonaismäärästä, toinen annosfraktio (F2D2) käsittää loput 50 % toissijaisen annoksen kokonaismäärästä ja F2D2 annetaan kohteelle 12—96 tunnin kuluttua F1D2:n antamisesta annostusohjelman viikon 2 aikana; ja annetaan kohteelle terapeuttisen proteiinin maksimiviikkoannos yhtenä annoksena — annostusohjelman seuraavalla viikolla, jolloin maksimiviikkoannos käsittää 80 mg, 160 mg tai 320 mg terapeuttista proteiinia, jolloin terapeuttinen proteiini on bispesifinen anti-CD20 x anti-CD3-vasta-aine, joka käsittää anti-CD20-sitoutumisvarren, joka käsittää raskasketjun, joka käsittää sekvenssin SEO ID NO: 10 mukaisen aminohapposekvenssin, ja kevytketjun, joka — käsittää sekvenssin SEO ID NO: 12 mukaisen aminohapposekvenssin, ja anti-CD3- sitoutumisvarren, joka käsittää raskasketjun, joka käsittää sekvenssin SEO ID NO: 11 mukaisen aminohapposekvenssin, ja kevytketjun, joka käsittää sekvenssin SEO ID NO: 12 mukaisen aminohapposekvenssin.1. A therapeutic protein for use in a method of treating CD20+ B-cell lymphoma, the method comprising administering to a subject a therapeutic protein in a dosing regimen to reduce the incidence or severity of cytokine release syndrome or — an infusion-related reaction, the method comprising: administering fractions of a primary dose (D1) of the therapeutic protein in week 1 of the dosing regimen, the primary dose comprising 1 mg of therapeutic protein, a first dose fraction (F1D1) comprising 50% of the total amount of the primary dose and administered to the subject on day 1 of week 1, and a second dose fraction (F2D1) comprising the remaining 50% of the total amount of the first dose and administered to the subject 12-96 hours after F1D1; administering a therapeutic = protein — secondary dose (D2) in fractions during week 2 of the dosing regimen, wherein the secondary dose comprises 20 mg of therapeutic — protein, the first dose fraction (F1D2) comprises 50% of the total secondary dose, the second dose fraction (F2D2) comprises the remaining 50% of the total secondary dose, and F2D2 is administered to the subject 12-96 hours after administration of F1D2 during week 2 of the dosing regimen; and administering to the subject the maximum weekly dose of the therapeutic protein as a single dose — in the following week of the dosing regimen, wherein the maximum weekly dose comprises 80 mg, 160 mg or 320 mg of the therapeutic protein, wherein the therapeutic protein is a bispecific anti-CD20 x anti-CD3 antibody comprising an anti-CD20 binding arm comprising a heavy chain comprising the amino acid sequence of SEQ ID NO: 10 and a light chain comprising — comprising the amino acid sequence of SEQ ID NO: 12, and an anti-CD3 binding arm comprising a heavy chain comprising the amino acid sequence of SEQ ID NO: 11 and a light chain comprising the amino acid sequence of SEQ ID NO: 12. 2. Terapeuttinen proteiini käytettäväksi patenttivaatimuksen 1 mukaisesti, — jolloin ensisijaisen annoksen tai toissijaisen annoksen toinen annosfraktio annetaan kohteelle 18—72 tuntia ensisijaisen annoksen tai toissijaisen annoksen ensimmäisen annosfraktion annon jälkeen.2. A therapeutic protein for use according to claim 1, - wherein the second dose fraction of the primary dose or secondary dose is administered to the subject 18-72 hours after administration of the first dose fraction of the primary dose or secondary dose. 3. Terapeuttinen proteiini käytettäväksi patenttivaatimuksen 1 tai 2 mukaisesti, jolloin seuraava viikko on viikko 3, viikko 4, viikko 14 tai mikä tahansa annostusohjelman viikoista 4-36.The therapeutic protein for use according to claim 1 or 2, wherein the next week is week 3, week 4, week 14, or any of weeks 4-36 of the dosing regimen. 4. Terapeuttinen proteiini käytettäväksi jonkin patenttivaatimuksista 1-3 mukaisesti, jolloin terapeuttisen proteiinin maksimiviikkoannos annetaan kohteelle yhtenä annoksena 1-8 viikon, 1—12 viikon tai 1-16 viikon ajan annostusohjelman viikoittaisen vaiheen aikana.4. The therapeutic protein for use according to any one of claims 1-3, wherein the maximum weekly dose of the therapeutic protein is administered to the subject in a single dose for 1-8 weeks, 1-12 weeks, or 1-16 weeks during the weekly phase of the dosing regimen. 5. Terapeuttinen proteiini käytettäväksi jonkin patenttivaatimuksista 1—4 mukaisesti, jolloin menetelmä käsittää lisäksi terapeuttisen proteiinin maksimiviikkoannoksen antamisen kohteelle yhtenä annoksena kerran kahdessa, kolmessa tai neljässä viikossa annostusohjelman ylläpitovaiheen aikana, joka seuraa annostusohjelman viikoittaisen vaiheen loppuun saattamista.5. The therapeutic protein for use according to any one of claims 1-4, wherein the method further comprises administering the maximum weekly dose of the therapeutic protein to the subject in a single dose once every two, three or four weeks during a maintenance phase of the dosing regimen following completion of the weekly phase of the dosing regimen. 6. Terapeuttinen proteiini käytettäväksi jonkin patenttivaatimuksista 1-5 mukaisesti, jolloin maksimiviikkoannos on 160 mg tai 320 mg.6. A therapeutic protein for use according to any one of claims 1 to 5, wherein the maximum weekly dose is 160 mg or 320 mg. T. Terapeuttinen proteiini käytettäväksi jonkin patenttivaatimuksista 1-6 mukaisesti, jolloin CD20+ B-solulymfooma on non-Hodgkin-lymfooma, Hodgkin- lymfooma, krooninen lymfaattinen leukemia, akuutti lymfoblastinen leukemia, — pienilymfosyyttinen lymfooma, diffuusi suurisoluinen B-solulymfooma, follikulaarinen lymfooma, manttelisolulymfooma, rajavyöhykelymfooma, Burkittin lymfooma, primaarinen mediastinaalinen B-solulymfooma, lymfoblastinen lymfooma tai Waldenströmin makroglobulinemia.T. A therapeutic protein for use according to any one of claims 1-6, wherein the CD20+ B-cell lymphoma is non-Hodgkin lymphoma, Hodgkin lymphoma, chronic lymphocytic leukemia, acute lymphoblastic leukemia, — small lymphocytic lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, borderline lymphoma, Burkitt lymphoma, primary mediastinal B-cell lymphoma, lymphoblastic lymphoma or Waldenström's macroglobulinemia. 8. Terapeuttinen proteiini käytettäväksi jonkin patenttivaatimuksista 1-6 — mukaisesti, jolloin kohteella on diagnosoitu: (i) follikulaarinen lymfooma tai asteen 1—3a follikulaarinen lymfooma; (ii) diffuusi suurisoluinen B-solulymfooma (DLBCL), valinnaisesti, jolloin kohteella on ollut aiempi epäonnistunut CAR-T-hoito; (ill) manttelisolulymfooma (MCL), valinnaisesti, jolloin kohteella on ollut aiempi — epäonnistunut Brutonin tyrosiinikinaasin (BTK) estohoito; tai8. A therapeutic protein for use according to any one of claims 1-6 — wherein the subject has been diagnosed with: (i) follicular lymphoma or grade 1-3a follicular lymphoma; (ii) diffuse large B-cell lymphoma (DLBCL), optionally wherein the subject has had prior failed CAR-T therapy; (iii) mantle cell lymphoma (MCL), optionally wherein the subject has had prior failed Bruton's tyrosine kinase (BTK) inhibition therapy; or (iv) rajavyöhykelymfooma (MZL).(iv) border zone lymphoma (MZL). 9. Terapeuttinen proteiini käytettäväksi jonkin patenttivaatimuksista 1-8 mukaisesti, jolloin terapeuttinen proteiini annetaan kohteelle yhdessä toisen aineen kanssa, joka valitaan seuraavista: steroidi, antihistamiini, asetaminofeeni, ei- — steroidinen tulehduskipulääke (NSAID), IL-6-antagonisti tai IL-6R-antagonisti.9. A therapeutic protein for use according to any one of claims 1-8, wherein the therapeutic protein is administered to a subject in combination with another agent selected from the group consisting of a steroid, an antihistamine, acetaminophen, a non-steroidal anti-inflammatory drug (NSAID), an IL-6 antagonist, or an IL-6R antagonist. 10. — Terapeuttinen proteiini käytettäväksi jonkin patenttivaatimuksista 1-9 mukaisesti, jolloin terapeuttinen proteiini annetaan kohteelle yhdessä toisen terapeuttisen aineen kanssa.10. — A therapeutic protein for use according to any one of claims 1 to 9, wherein the therapeutic protein is administered to the subject in combination with another therapeutic agent. 11. — Terapeuttinen proteiini käytettäväksi patenttivaatimuksen 10 mukaisesti, — jolloin toinen terapeuttinen aine: (a) käsittää ainakin yhtä seuraavista: rituksimabi, obinututsumabi, syklofofamidi, doksorubisiini, — vinkristiini, — prednisoni, — prednisoloni, — bendamustiini, lenalidomidi, klorambusiili, ibritumomabitiuksetaani, idelalisibi, kopanlisibi, duvelisibi, etoposidi, metyyliprednisoloni, sytarabiini, sisplatiini, mesna, ifosfamidi, mitoksantroni ja prokarbatsiini; (b) käsittää syklofosfamidin, doksorubisiinin, — vinkristiinin ja prednisonin yhdistelmän; (c) — käsittää ifosfamidin, sisplatiinin ja etoposidin yhdistelmän; (d) käsittää gemsitabiinin ja oksaliplatiinin yhdistelmän; (e) käsittää lenalidomidin ja rituksimabin yhdistelmän; tai (f) on lenalidomidi.11. — A therapeutic protein for use according to claim 10, — wherein the second therapeutic agent: (a) comprises at least one of the following: rituximab, obinutuzumab, cyclophosphamide, doxorubicin, — vincristine, — prednisone, — prednisolone, — bendamustine, lenalidomide, chlorambucil, ibritumomabitixetane, idelalisib, copanlisib, duvelisib, etoposide, methylprednisolone, cytarabine, cisplatin, mesna, ifosfamide, mitoxantrone and procarbazine; (b) comprises cyclophosphamide, doxorubicin, — a combination of vincristine and prednisone; (c) — comprises a combination of ifosfamide, cisplatin and etoposide; (d) comprises a combination of gemcitabine and oxaliplatin; (e) comprises a combination of lenalidomide and rituximab; or (f) is lenalidomide. 12. Terapeuttinen proteiini käytettäväksi jonkin patenttivaatimuksista 1-11 mukaisesti, jolloin (a) kohdetta on aiemmin hoidettu syövän vastaisella hoidolla; (b) kohde on refraktiivinen aikaisemmalle hoidolle tai sairaus on uusiutunut aiemman hoidon jälkeen; (c) kohdetta on aiemmin hoidettu anti-CD20-vasta-ainehoidolla; tai (d) kohdetta on aiemmin hoidettu CAR-T-hoidolla.12. A therapeutic protein for use according to any one of claims 1-11, wherein (a) the subject has been previously treated with anti-cancer therapy; (b) the subject is refractory to prior therapy or has relapsed after prior therapy; (c) the subject has been previously treated with anti-CD20 antibody therapy; or (d) the subject has been previously treated with CAR-T therapy. 13. Terapeuttinen proteiini käytettäväksi jonkin patenttivaatimuksista 1-12 mukaisesti, jolloin asteen 3 CRS:n ja IRR:n ilmaantuvuus on alle 10 % potilaiden populaatiossa, jotka saavat vähintään 80 mg:n maksimiviikkoannoksen.A therapeutic protein for use according to any one of claims 1 to 12, wherein the incidence of grade 3 CRS and IRR is less than 10% in the patient population receiving a maximum weekly dose of at least 80 mg. 14. —Terapeuttinen proteiini käytettäväksi patenttivaatimuksen 13 mukaisesti, jolloin asteen 3 CRS:n ja IRR:n esiintyvyys on alle 7,5 %.14. —Therapeutic protein for use according to claim 13, wherein the incidence of grade 3 CRS and IRR is less than 7.5%.
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